Senior Manager, Regulatory Strategic Planning

The Senior Manager, Regulatory Strategic Planning, is responsible for successfully delivering project management capabilities for cross-functional teams of medium- to high-complexity within and across the Regulatory Affairs organization. The individual combines knowledge of scientific, regulatory, and business processes to properly drive the execution of AbbVie’s regulatory strategies. Responsibilities include developing and managing the schedules, activities, and deliverables for the Global Regulatory Product Teams (GRPTs), interacting with key stakeholders, and leading process improvement efforts to help achieve business performance goals for regulatory compliance and productivity.

Responsibilities

Provides project management leadership in support of GRPTs; develops schedules and wave plans to ensure regulatory milestones are adequately planned and tracked and works with Regulatory staff across the globe to drive the execution of GRPT-related activities and deliverables. Works independently to plan and facilitate GRPT and related meetings (e.g., Dossier Kick-off Meetings, Regulatory Strategic Reviews, Rapid Response Teams, and Regulatory Advisory Panels); ensures action items are assigned and completed; periodically summarizes and shares team highlights with stakeholders as necessary. Interacts with ADTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; periodically communicates with Regulatory management to provide timely updates on progress and/or issues that may impact the global program. Drives GRPT operations in support of the Global Regulatory Lead (GRL); ensures GRPT-related information and tools (e.g., team sites, rosters, charters, schedules) are kept up to date. Plans and executes process improvement initiatives of medium- to high-complexity; demonstrates effective change leadership and is able to move ideas from concept to implementation. Possesses proficient knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; is able to provide business subject matter knowledge on assigned initiatives, and demonstrates effective problem solving & decision making, learning and adjusting behaviors based on prior results/experience. Leads team meetings effectively; uses the project governance process to effectively escalate and drive resolution of issues; demonstrates effective group facilitation skills and ability to drive consensus among team members regarding process changes. Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential written reports and presentations for a variety of audiences. Coordinates and drives deliverable preparation; develops and maintains process models using standard methods and tools; manages and tracks budgets, contracts, communications, metrics, and reporting-related processes. Supports mechanisms to identify, capture, and report business performance metrics. Analyzes metrics with subject matter experts in an effort to drive increase compliance, quality, and productivity across the organization.
Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.

Qualifications

Bachelor’s degree in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology), math, engineering, business management, or medical field Advanced degree in science, math, business management, or engineering is preferred. Certifications such as RAC from the Regulatory Affairs Professionals Society, and/or Project Management Institute (PMI) Project Management Professional (PMP) are preferred 7 years’ related experience Proven leadership skills and presence Experience working in a complex and matrix environment Strong verbal and written communication skills Ability to interact with senior management and executives

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.